Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age - Tabular View

Tracking Information

First Received Date ^ICMJE

October 11, 2005

Last Updated Date

April 9, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00238576 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age

Official Title ^ICMJE

Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age

Brief Summary

This project will expand current knowledge of reproductive biology in women with bipolar disorder as well as assessing the impact of lamotrigine use for the treatment of bipolar disorder on reproductive function. Specifically, this study examines mood over the menstrual cycle and ovulation for three consecutive menstrual cycles in women treated for bipolar I, II, or NOS (not otherwise specified) with lamotrigine. In addition, testosterone and lipid concentrations will be measured before the participant starts receiving lamotrigine, as well as six months after receiving lamotrigine.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Prospective

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria::

Female
Ages 18 through 45
Diagnosis of bipolar disorder (I, II, or NOS)
Willing to sign the Human Subject Protection Consent Form prior to enrollment into the study
Willing to use lamotrigine
Never used lamotrigine prior to study entry Exclusion Criteria:- Unwilling or unable to comply with study requirements, e.g. complete forms, or attend scheduled evaluations
Significant alcohol and/or substance abuse or dependence within the prior 6 months
Used lamotrigine prior to study entry, or currently using lamotrigine at study entry

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00238576

Responsible Party

Study ID Numbers ^ICMJE

79890, SPO# 30264

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Dr Natalie Rasgon

Stanford University

Information Provided By

Stanford University

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP